BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL ELITE PRO

    MDR report key: 2538469 · Received April 6, 2012

    Report

    Report Number
    1217183-2012-00005
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    February 28, 2012
    Report Date
    April 6, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    PMA / PMN Number
    K060162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IS BEING RETURNED TO MANUFACTURER TO ASSESS DAMAGE. RISK ASSESSMENT IF PENDING.

    Description of Event or Problem · 1

    CUSTOMER STATED ONE OF THEIR TECHNICIANS SPILLED WASH-R SOLUTION ON THE INSTRUMENT WHILE REPLACING IT. THE INSTRUMENT CAUGHT FIRE BUT IT STOPPED BURNING ONCE THE INSTRUMENT WAS UNPLUGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL ELITE PRO COAGULATION INSTRUMENT JPA INSTRUMENTATION LABORATORY CO. ACL ELITE PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1